LivaNova Concludes PRELUDE Study for Caisson TMVR System


August 6, 2018—LivaNova PLC announced the conclusion of the PRELUDE feasibility study for its Caisson transcatheter mitral valve replacement (TMVR) system. The PRELUDE first-in-human study evaluated the Company’s TMVR system to treat moderate to severe mitral regurgitation (MR) using a transseptal approach.

After the positive patient outcomes from the PRELUDE study, the company will now focus on enrolling patients in the INTERLUDE CE Mark trial and finalizing the protocol for the ENSEMBLE United States pivotal trial with the FDA. The INTERLUDE trial will be conducted in North American and European centers with enrollment completion expected by 2020.

The PRELUDE study's Principal Investigator, Mathew Williams, MD, commented in the company's announcement, “Patients with moderate-to-severe mitral regurgitation are often too sick for traditional open-heart surgery. We saw encouraging outcomes in patients within the PRELUDE trial. Follow-up results showed positive acute valve performance, which was maintained over time, along with improved quality of life.” Dr. Williams added, “We are pleased to continue our TMVR research with the INTERLUDE trial.”


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.